Unapproved Otic Products Subject to FDA Seizure

The FDA is taking enforcement actions against manufacturers and distributors of unapproved prescription eardrops.

The FDA is taking enforcement actions against manufacturers and distributors of unapproved prescription eardrops.

These otic products claim to relieve ear pain, infection, and inflammation, but have not been evaluated for safety, effectiveness, and quality. Because the products’ labels do not disclose that they lack FDA approval, health care professionals may be unaware of related risks.

“Taking enforcement actions against these unapproved products will protect patients from unnecessary risks,” stated Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

Unapproved prescription otic products subject to seizure, injunction, and other potential enforcement actions contain active ingredients such as benzocaine, antipyrine, zinc acetate, chloroxylenol, pramoxine, and hydrocortisone. The FDA’s actions do not affect approved prescription otic products or legally marketed OTC otic products.

Unapproved prescription otic drug products are frequently given to young children with ear pain and swelling. These products may be contaminated or manufactured incorrectly, however, which could result in patients receiving the wrong dose despite following the directions labeled.

Those using unapproved prescription eardrops should discuss alternatives with their health care provider, the FDA advised. Health care professionals and consumers should also report any related adverse events to the FDA’s MedWatch Adverse Event Reporting program.